Validation Technician II: IQ/OQ/PQ & Report Expert

AMERICAN REGENT, INC.; New Albany (OH); On-site; USD 60,000 - 85,000; Full time

Job summary

American Regent, Inc. seeks a Validation Technician II to oversee validation protocols for equipment and utilities in sterile drug product manufacturing. You will execute IQ/OQ/PQ protocols, generate final reports, and support deviations investigation under supervision.

The role requires strong MS-Office skills, technical writing ability, and the capacity to work independently with minimal supervision. Compliance with FDA/cGMP and safety requirements is essential.

Qualifications

• High School Diploma or GED Equivalent and 2 years of relevant work experience required.
• Associate’s degree and 1 year of relevant work experience or Bachelor’s Degree in Life Science, Engineering or related field required.
• Strong knowledge of MS-Office software and PC skills required.
• Good scientific technical writing skills.
• Excellent written and verbal communication, problem-solving, planning and organization skills.
• Ability to work independently with minimum supervision.

Responsibilities

• Assist in developing validation protocols (IQ, OQ, PQ) and coordinate protocol approval.
• Improve processes and procedures and resolve problems.
• Draft SOPs and Training Modules for the department.
• Support monitoring programs and assist with training of personnel.
• Plan and coordinate validation project activities and protocol execution.
• Perform execution of protocols and produce report summaries.
• Analyze validation data to ensure it meets acceptance criteria.
• Coordinate requalification events and input for deviations.

Skills

MS Office

Technical writing

Communication

Planning

Independent work

Thermal mapping

Problem solving

Education

Associate’s degree in Life Science or Engineering

Bachelor’s Degree in Life Science or Engineering

Tools

Kaye Validator 2000

Ellab Val Suite Software

ValGenesis

Job description

American Regent, Inc. seeks a Validation Technician II to oversee validation protocols for equipment and utilities in sterile drug product manufacturing. You will execute IQ/OQ/PQ protocols, generate final reports, and support deviations investigation under supervision.

The role requires strong MS-Office skills, technical writing ability, and the capacity to work independently with minimal supervision. Compliance with FDA/cGMP and safety requirements is essential.